Method and device for secluding a body vessel

ABSTRACT

A device for secluding a body vessel may include a distal balloon, a proximal balloon, an aspiration port positioned adjacent to the distal balloon, an injection port positioned adjacent to the proximal balloon, and a lumen assembly. The lumen assembly may comprise a central lumen, a distal balloon lumen operably coupled to the distal balloon, a proximal balloon lumen operably coupled to the proximal balloon, an aspiration port lumen operably coupled to the aspiration port, and an injection port lumen operably coupled to the injection port. The distal balloon and the proximal balloon may define a treatment chamber therebetween, and the aspiration port and the injection port may be positioned within the treatment chamber on the lumen assembly.

FIELD OF THE INVENTION

The following invention generally relates to the field of body vesselseclusion.

BACKGROUND OF THE INVENTION

For certain medical conditions, it may be necessary or desirable toseclude (i.e., to close off, collapse, or significantly narrow) a bodyvessel such as a vein or artery. One situation in which seclusion may bedesirable is in the treatment of varicose veins, which are swollen,twisted, or enlarged veins that may be visible under a patient's skin.By closing off the varicose vein, blood ceases to flow in the varicosevein and is naturally redirected to healthy veins. Over time, theclosed-off vein may be completely absorbed into surrounding tissue.

There are several techniques currently in use for secluding a bloodvessel such as a varicose vein. Examples of these techniques includesurgery, heat ablation, and chemical treatment. Surgically, veins may besubjected to a seclusion procedure known as ligation. During ligation, asmall incision may be made near the target vein and the vein may be tiedoff. The ligated vein may be left in place and absorbed into surroundingtissue, as noted above. Alternatively, the ligated vein may be removedby a process known as “stripping” the vein. The surgical treatment ofveins in this manner is sometimes referred to as phlebectomy.

The surgical treatment of varicose veins is generally effective, but maycarry certain risks and disadvantages. The procedure is relativelyinvasive compared to other varicose vein treatment methods, andaccordingly may be painful for some patients. Surgical treatment ofvaricose veins also carries a risk of nerve injury, may require the useof general anesthesia and an overnight hospital stay, and may require arelatively long recovery time. Accordingly, other types of veintreatment have been developed. These treatments generally involvedamaging the walls of the vein, which causes the vein walls to collapse,close, or narrow. For example, in heat ablation treatment, a heat source(typically a laser or radio frequency transmitter) may be inserted intothe vein through a catheter. Upon reaching a target area of the vein,the heat source may be turned on for a predetermined period of time,which damages the target area of the vein and causes scar tissue to formon the inner walls of the vein. The build-up of scar tissue closes thevein. Problematically, the same heat that damages the vein can alsodamage surrounding tissue and nearby nerves. It can also cause skinburns and blood clots, and may not be appropriate for all types ofveins.

The vein walls can also be damaged chemically in a procedure known assclerotherapy. In sclerotherapy, a chemical known as a sclerosing agentmay be injected into the vein. The sclerosing agent may damage the wallsof the vein and cause the vein to narrow or close. However, in order tobe effective, the sclerosing agent needs to remain in contact with theinside walls of the target area of the vein for some time (e.g., up toone minute). This is difficult to achieve using conventionalsclerotherapy procedures because the sclerosing agent may be quicklywashed away by the flow of blood through the vein. As a result, thesclerosing agent may be diluted and flow to other portions of the body,and hence the sclerosing agent may not be sufficiently effective toclose the vein upon an initial application. Accordingly, patients mayneed several treatment sessions with one or more injections ofsclerosing agent applied in each session. In order to address theseissues, a new sclerotherapy treatment method called catheter-directedfoam sclerotherapy (“CDFS”) has recently been employed. In this method,a catheter is inserted into the vein and moved to the target site. Thesclerosing agent is injected into the vein through the catheter in theform of a foam. Because the agent is a foam, it is relatively moredifficult for the blood flow to dilute and remove the sclerosing agent.Therefore, as compared to conventional sclerotherapy, CDFS allows thesclerosing agent to be present at the target site for a relativelylonger period of time, in a relatively larger concentration.Nonetheless, the sclerosing agent will still be washed away from thetarget site due to the flow of the blood in the vein, so repeatedtreatments may remain necessary.

Therefore there at least remains a need in the art for a method anddevice for secluding a body vessel such that a sclerosing agent may bemaintained at the target site without being washed away due to bloodflow in the vessel.

SUMMARY OF THE INVENTION

One or more embodiments of the invention may address one or more of theaforementioned problems. In one aspect, a device for secluding a bodyvessel is provided. In accordance with certain embodiments, the devicemay include a distal balloon, a proximal balloon, an aspiration portpositioned adjacent to the distal balloon, an injection port positionedadjacent to the proximal balloon, and a lumen assembly. The lumenassembly may comprise a central lumen, a distal balloon lumen operablycoupled to the distal balloon, a proximal balloon lumen operably coupledto the proximal balloon, an aspiration port lumen operably coupled tothe aspiration port, and an injection port lumen operably coupled to theinjection port. The distal balloon and the proximal balloon may define atreatment chamber therebetween, and the aspiration port and theinjection port may be positioned within the treatment chamber on thelumen assembly.

In another aspect, a method for secluding a body vessel is provided. Inaccordance with certain embodiments, the method may include removingblood from a treatment chamber in the body vessel via an aspirationport, delivering a chemical agent to the treatment chamber via aninjection port, maintaining the chemical agent in the treatment chamberfor a predetermined period of time to seclude the body vessel within thetreatment chamber, and removing the chemical agent from the treatmentchamber via the aspiration port. The aspiration port may be operablycoupled to an aspiration port lumen of a vessel seclusion device, andthe injection port may be operably coupled to an injection port lumen ofthe vessel seclusion device.

In yet another aspect, another method for secluding a body vessel isprovided. In accordance with certain embodiments, the method may includeselecting a seclusion length of the body vessel such that the seclusionlength has a starting point and an ending point, dividing the seclusionlength into at least two treatment chambers, secluding the firsttreatment chamber with a vessel seclusion device, moving the vesselseclusion device to the second treatment chamber, and secluding thesecond treatment chamber. The first treatment chamber may be defined bythe starting point and a first intermediate point, and the secondtreatment chamber may be defined by the first intermediate point and theending point. Secluding each of the first treatment chamber and thesecond treatment chamber may comprise removing blood from the treatmentchamber in the body vessel via an aspiration port, delivering a chemicalagent to the treatment chamber via an injection port, maintaining thechemical agent in the treatment chamber for a predetermined period oftime to seclude the body vessel within the treatment chamber, andremoving the chemical agent from the treatment chamber via theaspiration port. The aspiration port may be operably coupled to anaspiration port lumen of a vessel seclusion device, and the injectionport may be operably coupled to an injection port lumen of the vesselseclusion device.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allembodiments of the invention are shown. The present invention may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements and demonstrate exemplary embodiments of the invention.Repeat use of reference characters in the present specification anddrawings is intended to represent same or analogous features or elementsof the invention.

FIG. 1 illustrates a partial view of a device for secluding a bodyvessel in a pre-deployed form according to an example embodiment;

FIG. 2 illustrates a device for secluding a body vessel including thelumens according to an example embodiment;

FIG. 3 illustrates a cross-section of a lumen assembly in a device forsecluding a body vessel according to an example embodiment;

FIG. 4 illustrates a partial view of a device for secluding a bodyvessel in a deployed form according to an example embodiment;

FIG. 5 illustrates a body vessel with an identified area to be secludedaccording to an example embodiment;

FIG. 6 illustrates a block diagram of a method of secluding a bodyvessel according to an example embodiment; and

FIG. 7 illustrates a block diagram of a method of secluding a bodyvessel according to an example embodiment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Reference will now be made in detail to exemplary embodiments of theinvention, one or more examples of which are illustrated in theaccompanying drawings. Each example is provided by way of explanation ofthe invention, not limitation of the invention. In fact, it will beapparent to those skilled in the art that modifications and variationscan be made in the present invention without departing from the scope orspirit thereof. For instance, features illustrated or described as partof one embodiment may be used on another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncovers such modifications and variations as come within the scope of theappended claims and their equivalents.

In contrast to conventional treatment methods and devices, the exemplaryembodiments disclosed herein may be less invasive and may require lessrecovery time. Moreover, the exemplary embodiments disclosed herein mayeliminate the need for a general anesthetic, instead relying on a localanesthetic. In this regard, the exemplary embodiments disclosed hereinmay reduce procedural risks and further decrease required recovery time.In addition, the exemplary embodiments disclosed herein may beassociated with a reduced risk of nerve damage, skin damage, andrecovery pain.

As used herein, the term “body vessel” may comprise any lumen or othersimilar region in a body, such as a blood vessel or the intestines.Although specific examples are provided herein with reference to veins,one of ordinary skill in the art will recognize that the device andmethods disclosed herein are not limited to these particular examplesbut rather may be employed in any suitable body vessel.

The term “seclusion”, as used herein, may refer to the narrowing,collapsing, or closing off of a body vessel. Accordingly, seclusion maybe distinct from therapies intended to open or widen a vessel and fromtherapies intended to prevent the vessel from narrowing. The term“two-point seclusion”, as used herein, may refer to secluding the bodyvessel at two points with a narrowed, collapsed, or closed space betweenthe points.

For ease of reference, exemplary embodiments will be described in termsof use in human subjects. It will be understood, however, that suchdescriptions are not limited to use to humans, but will also include usein other animals unless explicitly stated otherwise. Moreover, althougha catheter is referred to herein, one of ordinary skill in the art willrecognize that a catheter is merely an exemplary device as disclosedherein.

In one aspect, a device for secluding a body vessel is provided. Inaccordance with certain embodiments, the device for secluding a bodyvessel may include a distal balloon, a proximal balloon, an aspirationport positioned adjacent to the distal balloon, an injection portpositioned adjacent to the proximal balloon, and a lumen assembly. Insome embodiments, for instance, the lumen assembly may comprise acentral lumen, a distal balloon lumen operably coupled to the distalballoon, a proximal balloon lumen operably coupled to the proximalballoon, an aspiration port lumen operably coupled to the aspirationport, and an injection port lumen operably coupled to the injectionport. In certain embodiments, for example, the distal balloon and theproximal balloon may define a treatment chamber therebetween, and theaspiration port and the injection port may be positioned within thetreatment chamber on the lumen assembly.

FIG. 1, for instance, illustrates a partial view of a device forsecluding a body vessel in a pre-deployed form according to an exampleembodiment. As shown in FIG. 1, for example, the device may be acatheter. The catheter may include a lumen assembly 10, a proximalballoon 20, an injection port 25 positioned adjacent to the proximalballoon 20, a distal balloon 30, and an aspiration port 35 positionedadjacent to the distal balloon 30. The proximal balloon 20 and thedistal balloon 30 may define a treatment chamber 40 therebetween insideof a body vessel 50 when the balloons 20, 30 are inflated. In thisregard, for example, a chemical agent may be introduced into thetreatment chamber 40 to seclude the body vessel 50 within the treatmentchamber 40. The balloons 20, 30 may be made of any suitable material asunderstood by one of ordinary skill in the art including, but notlimited, to polymeric materials. In accordance with certain embodiments,for example, the body vessel 50 may comprise at least one of a varicosevein, a portal vein, a perforator vein, a superficial vein, a peripheralvein, an arteriovenous malformation, or any combination thereof. Thecatheter may be of any length suitable for secluding a variety of bodyvessels as understood by one of ordinary skill in the art (e.g., 100cm).

According to certain embodiments, for instance, the treatment chamber 40may comprise a length from about 3 cm to about 15 cm. In someembodiments, for example, the treatment chamber 40 may comprise a lengthfrom about 5 cm to about 10 cm. In further embodiments, for instance,the treatment chamber 40 may comprise a length from about 6 cm to about8 cm. In certain embodiments, for example, the treatment chamber 40 maycomprise a length of about 7 cm. As such, in certain embodiments, thetreatment chamber 40 may comprise a length from at least about any ofthe following: 3, 4, 5, 6, and 7 cm and/or at most about 15, 12, 10, 9,8, and 7 cm (e.g., about 4-9 cm, about 6-12 cm, etc.).

The lumen assembly 10 may comprise a flexible tube having several hollowlumens therein as described in more detail below. The individual lumensmay not be very flexible. For example, the individual lumens within thelumen assembly 10 may only bend and/or move from about 2 mm to about 3mm. However, the lumen assembly 10 may be sufficiently flexible tonavigate through the body vessels of an individual. For instance, thelumen assembly 10 may be used to guide the device into position insidethe body vessel 50, for example, via a guide wire 5.

According to certain embodiments, for instance, the guide wire 5 maycomprise a diameter from about 0.001 cm to about 0.025 cm. In someembodiments, for example, the guide wire 5 may comprise a diameter fromabout 0.01 cm to about 0.02 cm. In further embodiments, for instance,the guide wire 5 may comprise a diameter from about 0.015 cm to about0.019 cm. In other embodiments, for example, the guide wire 5 maycomprise a diameter of about 0.018 cm. As such, in certain embodiments,the guide wire 5 may comprise a diameter from at least about any of thefollowing: 0.001, 0.005, 0.01, 0.015, 0.016, 0.017, and 0.018 cm and/orat most about 0.025, 0.024, 0.023, 0.022, 0.021, 0.02, 0.019, and 0.018cm (e.g., about 0.01-0.019 cm, about 0.017-0.024 cm, etc.). However, theguide wire 5 may comprise any guide wire suitable for use with thedevice disclosed herein as understood by one of ordinary skill in theart.

In accordance with certain embodiments, for instance, the lumen assembly10 may include the injection port 25 and the aspiration port 35 tointroduce and evacuate fluids respectively. In certain embodiments, forexample, the injection port 25 and the aspiration port 35 may bepositioned on the lumen assembly 10 within the treatment chamber 40created by the inflated proximal balloon 20 and the distal balloon 30.In some embodiments, for example, each of the aspiration port 35 and theinjection port 25 comprise a port orifice and a one-way valve at theport orifice. In this regard, for instance, the aspiration port 35 mayevacuate blood and other bodily fluids from the treatment chamber 40 toprovide an empty area for the chemical agent to occupy and to preventthe chemical agent from being diluted. Additionally, the aspiration port35 may evacuate the chemical agent from the treatment chamber 40 aftertreatment. Moreover, the injection port 25 may introduce the chemicalagent into the treatment chamber 40 to initiate seclusion of the bodyvessel 50.

FIG. 2, for instance, illustrates a device for secluding a body vesselincluding the lumens according to an example embodiment. As shown inFIG. 2, for example, the lumen assembly 10 divides into individuallumens outside of the body vessel 50. The individual lumens include adistal balloon lumen 11, a proximal balloon lumen 12, a central lumen13, an injection port lumen 14, and an aspiration port lumen 15. FIG. 3,for instance, illustrates a cross-section of the lumen assembly 10 in adevice for secluding a body vessel according to an example embodiment.As shown in FIG. 3, for example, the lumen assembly 10 channels each ofthe lumens 11-15 through a single tube such that the distal balloonlumen 11, the proximal balloon lumen 12, the injection port lumen 14,and the aspiration port lumen 15 are arranged around the central lumen13 such that the two balloon lumens 11, 12 are positioned diagonallyacross from each other within the lumen assembly 10. The two port lumens14, 15 are similarly positioned diagonally across from each other withinthe lumen assembly 10.

According to certain embodiments, for example, the central lumen 13 isconfigured to introduce the guide wire 5 into the body vessel 50. Priorto the guide wire 5 moving through the central lumen 13, the body vessel50 may be prepared. For example, an incision in a patient's skin may bemade, and the body vessel 50 may be opened at the location of theincision. The guide wire 5 may then be inserted into the opening in thebody vessel 50 and threaded through the body vessel 50 under guidance ofa visualization device (e.g., ultrasound 95), as described in moredetail below. When the guide wire 5 reaches the appropriate treatmentpoint within the body vessel 50, the central lumen 13 may be threadedover the guide wire 5 and into the body vessel 50. The central lumen 13(and similarly the entire device) may be pushed along the length of theguide wire 5 until the distal balloon 30 is in a suitable location inthe body vessel 50 as indicated by the visualization device.

According to certain embodiments, for instance, the aspiration port 35and the aspiration port lumen 15 may be configured to remove at leastone of blood, bodily fluid, a chemical agent, or any combination thereoffrom the treatment chamber 40. In further embodiments, for example, theinjection port 25 and the injection port lumen 14 may be configured todeliver a chemical agent to the treatment chamber 40.

Moreover, according to certain embodiments, for instance, the proximalballoon 20 and the distal balloon 30 may be inflated through theproximal balloon lumen 12 and the distal balloon lumen 11 respectively.The balloons 20, 30 may be inflated using air or any other suitablefluid as understood by one of ordinary skill in the art. In this regard,the inflation of the balloons 20, 30 may secure the catheter in placeand isolate the treatment chamber 40.

FIG. 4, for example, illustrates a partial view of a device forsecluding a body vessel in a deployed form according to an exampleembodiment. As shown in FIG. 4, for instance, the balloons 20, 30 areinflated to define the treatment chamber 40. To define the treatmentchamber 40, for example, the proximal balloon 20 and the distal balloon30 may be inflated with a fluid. When inflated, for instance, theinterior sides of the distal balloon 30 and the proximal balloon 20(i.e. the sides facing internally towards each other) may define theouter limits (e.g., starting point 60 and ending point 70) of thetreatment chamber 40. For example, the proximal and distal balloons 20,30 may be sized so that, when inflated, the outer ends of the balloons20, 30 contact the interior surface of the body vessel 50 and form aseal, preventing fluids from entering or leaving the treatment chamber40. According to certain embodiments, each of the distal balloon 30 andthe proximal balloon 20 are spherical. However, the balloons 20, 30 maybe any shape suitable for use in the device as understood by one ofordinary skill in the art.

In some embodiments, for instance, the distal balloon 30 may comprise aninflated distal balloon diameter, the proximal balloon 20 may comprisean inflated proximal balloon diameter, and each of the inflated distalballoon diameter and the inflated proximal balloon diameter may be fromabout 5 mm to about 20 mm. In further embodiments, for example, each ofthe inflated distal balloon diameter and the inflated proximal balloondiameter may be from about 7 mm to about 15 mm. In other embodiments,for instance, each of the inflated distal balloon diameter and theinflated proximal balloon diameter may be from about 8 mm to about 12mm. As such, in certain embodiments, each of the inflated distal balloondiameter and the inflated proximal balloon diameter may be from at leastabout any of the following: 5, 6, 7, and 8 mm and/or at most about 20,19, 18, 17, 16, 15, 14, 13, and 12 mm (e.g., about 6-18 mm, about 5-14mm, etc.).

In another aspect, a method for secluding a body vessel is provided. Inaccordance with certain embodiments, the method may include removingblood from a treatment chamber 40 in the body vessel 50 via anaspiration port 35, delivering a chemical agent to the treatment chamber40 via an injection port 25, maintaining the chemical agent in thetreatment chamber 40 for a predetermined period of time to seclude thebody vessel 50 within the treatment chamber 40, and removing thechemical agent from the treatment chamber 40 via the aspiration port 35.The aspiration port 35 may be operably coupled to an aspiration portlumen 15 of a vessel seclusion device (e.g., catheter), and theinjection port 25 may be operably coupled to an injection port lumen 14of the vessel seclusion device.

FIG. 6, for example, illustrates a block diagram of a method ofsecluding a body vessel 50 according to an example embodiment. As shownin FIG. 6, for instance, the method includes the initial steps ofinserting a guide wire 5 into the body vessel 50 via a central lumen 13of the vessel seclusion device at operation 110, inserting at least aportion of the vessel seclusion device into the body vessel 50 via theguide wire 5 at operation 120, positioning the vessel seclusion devicewithin the body vessel 50 via ultrasound 95 at operation 130, andinflating a distal balloon 30 and a proximal balloon 20 of the vesselseclusion device within the body vessel 50 to define the treatmentchamber 40 at operation 140. The method continues with the primarytreatment steps of removing blood from the treatment chamber 40 in thebody vessel 50 via an aspiration port 35 at operation 150, delivering achemical agent to the treatment chamber 40 via an injection port 25 atoperation 160, maintaining the chemical agent in the treatment chamber40 for a predetermined period of time to seclude the body vessel 50within the treatment chamber 40 at operation 170, and removing thechemical agent from the treatment chamber 40 via the aspiration port 35at operation 180.

In accordance with certain embodiments, for instance, the chemical agentmay be any agent known to chemically damage the body vessel 50 intowhich the catheter has been introduced, thereby causing the body vessel50 to narrow or close. In some embodiments, for example, the chemicalagent may be a sclerosing agent typically used in sclerotherapyincluding, but not limited to, polidocanol, sotra-decol, hypertonicsaline, or any other chemical agent suitable for damaging the vessel inthe context of the sclerosing effect as understood by one of ordinaryskill in the art. Alternatively or in addition, for instance, thechemical agent may be an agent known to elicit a biological responsefrom the body vessel 50 into which the catheter has been introduced. Insuch embodiments, for example, the agent may be selected so as to inducethe biological reaction substantially immediately after the catheter iswithdrawn from the treatment chamber 40 (i.e. the body vessel 50 closesor narrows around the catheter as the catheter is withdrawn from thebody vessel 50). In this regard, the body vessel 50 may be caused toimmediately close following application of the chemical agent (ascompared to traditional sclerotherapies, in which the vessel may takeseveral days, or even several weeks, to close following application ofthe sclerosing agent).

According to certain embodiments, for example, after evacuating thetreatment chamber 40 of all blood and/or other bodily fluids via theaspiration port lumen 15 and the aspiration port 35, a chemical agentmay be introduced into the treatment chamber 40 via the injection portlumen 14 and injection port 25 and then maintained in the treatmentchamber 40 for a predetermined amount of time due to the inflatedballoons 20, 30. In some embodiments, for instance, maintaining thechemical agent in the treatment chamber for the predetermined period oftime may comprise maintaining the chemical agent in the treatmentchamber for up to one minute (i.e. from about 1 second to about 60seconds). As such, in certain embodiments, for instance, the chemicalagent may be maintained in the treatment chamber for a time from atleast about any of the following: 1, 5, 10, 20, 30, 40, 50, and 60seconds and/or at most 60 seconds (e.g., about 5-60 seconds, about 30-60seconds, etc.). In this regard, the chemical agent remains in contactwith walls of the body vessel 50 in the treatment chamber 40 for asufficient amount of time to seclude the body vessel 50 without beingdiluted or washed away by the flow of fluid in the body vessel 50shortly after introduction of the chemical agent. After thepredetermined period of time, the chemical agent may be removed from thebody vessel 50 via the aspiration port 35 and the aspiration port lumen15. If the treatment chamber 40 fully encompassed the area to besecluded, the balloons 20, 30 may be deflated and the catheter may bewithdrawn from the body vessel 50 through the original incision. Theoriginal incision in the body vessel 50 and/or skin may then be closed(e.g., via sutures). In this regard, the body vessel 50 may be secludedbetween two points (e.g., the starting point 60 and the ending point 70in FIG. 4).

Following treatment, a patient will typically be capable of walkingimmediately and can return home after the procedure (i.e. the patientdoes not need to remain in a hospital overnight). The body vessel 50 maybe secluded immediately, as opposed to conventional sclerotherapy, whichmay require additional time following treatment and/or multipletreatments in order to seclude the body vessel 50, and the body vessel50 may be absorbed into surrounding tissue over a period of severalmonths. The patient may be scheduled for a follow-up visit to verifythat the body vessel 50 has been properly secluded and absorbed. If aproblem is noted at the follow-up visit, for instance, the patient mayundergo another round of treatment using the methods and devicesdisclosed herein or may be treated using a different method. In thisregard, the methods disclosed herein may be used in combination withother conventional treatments.

In yet another aspect, another method for secluding a body vessel isprovided. In accordance with certain embodiments, the method may includeselecting a seclusion length of the body vessel such that the seclusionlength has a starting point and an ending point, dividing the seclusionlength into at least two treatment chambers, secluding the firsttreatment chamber with a vessel seclusion device (e.g., catheter),moving the vessel seclusion device to the second treatment chamber, andsecluding the second treatment chamber. The first treatment chamber maybe defined by the starting point and a first intermediate point, and thesecond treatment chamber may be defined by the first intermediate pointand the ending point. Secluding each of the first treatment chamber andthe second treatment chamber may comprise removing blood from thetreatment chamber in the body vessel via an aspiration port, deliveringa chemical agent to the treatment chamber via an injection port,maintaining the chemical agent in the treatment chamber for apredetermined period of time to seclude the body vessel within thetreatment chamber, and removing the chemical agent from the treatmentchamber via the aspiration port as previously discussed herein. Theaspiration port may be operably coupled to an aspiration port lumen of avessel seclusion device, and the injection port may be operably coupledto an injection port lumen of the vessel seclusion device.

FIG. 7, for example, illustrates a block diagram of a method ofsecluding a body vessel according to an example embodiment. As shown inFIG. 7, for instance, the method includes selecting a seclusion lengthof the body vessel at operation 210, dividing the seclusion length intoat least two treatment chambers at operation 220, secluding the firsttreatment chamber with a vessel seclusion device at operation 230,moving the vessel seclusion device to the second treatment chamber atoperation 240, and secluding the second treatment chamber at operation250. In this regard, if the seclusion length 100 extends beyond onetreatment chamber 40, the catheter may be partially withdrawn in orderto reposition the treatment chamber 40 at a new location along theseclusion length 100.

According to certain embodiments, for instance, the seclusion length 100may be from about 3 cm to about 100 cm. In other embodiments, forexample, the seclusion length 100 may be from about 7 cm to about 90 cm.In further embodiments, for instance, the seclusion length 100 may befrom about 15 cm to about 80 cm. In some embodiments, for example, theseclusion length 100 may be from about 60 cm to about 70 cm. As such, incertain embodiments, the seclusion length 100 may be from at least aboutany of the following: 3, 5, 7, 10, 15, 20, 30, 40, 50, and 60 cm and/orat most about 100, 95, 90, 85, 80, 75, and 70 cm (e.g., about 5-70 cm,about 50-60 cm, etc.).

In accordance with certain embodiments, for example, the seclusionlength may comprise at least three treatment chambers. In suchembodiments, for instance, the first treatment chamber may be defined bythe starting point and the first intermediate point, the secondtreatment chamber may be defined by the first intermediate point and asecond intermediate point, and a third treatment chamber may be definedby the second intermediate point and the ending point. FIG. 5, forinstance, illustrates a body vessel with an identified area to besecluded according to an example embodiment. As shown in FIG. 5, forexample, the seclusion length 100 is divided into three treatmentchambers, with the first treatment chamber to be located between thestarting point 60 and the first intermediate point 70, the secondtreatment chamber to be located between the first intermediate point 70and the second intermediate point 80, and the third treatment chamber tobe located between the second intermediate point 80 and the ending point90.

According to certain embodiments, moving the vessel seclusion devicecomprises positioning the vessel seclusion device within the body vessel50 via ultrasound 95. Ultrasound 95 may be used to position the vesselseclusion device because it is not invasive and does not require specialequipment to be deployed on the catheter or guide wire 5.

In this regard, the catheter may initially be positioned such that thetreatment chamber 40 lies between the starting point 60 and the firstintermediate point 70. Following application of the chemical agentbetween these points 60, 70, the catheter may be repositioned so thatthe distal balloon 30 is positioned at the first intermediate point 70and the proximal balloon 20 is positioned at the second intermediatepoint 80. The method may be repeated until the full seclusion length 100has been treated such that the proximal balloon 20 is positioned at theending point 90.

EXEMPLARY EMBODIMENTS

Certain exemplary embodiments provide a device for secluding a bodyvessel. For instance, this device provides a less invasive, lessdamaging means for secluding body vessels having a reduced recovery timeand that is less likely to require multiple applications. In one aspect,the device for secluding a body vessel includes a distal balloon, aproximal balloon, an aspiration port positioned adjacent to the distalballoon, an injection port positioned adjacent to the proximal balloon,and a lumen assembly. According to certain embodiments, the lumenassembly comprises a central lumen, a distal balloon lumen operablycoupled to the distal balloon, a proximal balloon lumen operably coupledto the proximal balloon, an aspiration port lumen operably coupled tothe aspiration port, and an injection port lumen operably coupled to theinjection port. In some embodiments, the distal balloon and the proximalballoon define a treatment chamber therebetween, and the aspiration portand the injection port are positioned within the treatment chamber onthe lumen assembly. In certain embodiments, the treatment chambercomprises a length from about 3 cm to about 15 cm. In furtherembodiments, the central lumen is configured to introduce a guide wireinto the body vessel.

In accordance with certain embodiments, each of the aspiration port andthe injection port comprise a port orifice and a one-way valve at theport orifice. In some embodiments, the aspiration port and theaspiration port lumen are configured to remove at least one of blood,bodily fluid, a chemical agent, or any combination thereof from thetreatment chamber. In further embodiments, the injection port and theinjection port lumen are configured to deliver a chemical agent to thetreatment chamber.

According to certain embodiments, each of the distal balloon and theproximal balloon are spherical. In some embodiments, the distal ballooncomprises an inflated distal balloon diameter, the proximal ballooncomprises an inflated proximal balloon diameter, and each of theinflated distal balloon diameter and the inflated proximal balloondiameter is from about 5 mm to about 20 mm.

In another aspect, certain embodiments provide a method for secluding abody vessel. According to certain embodiments, the method includesremoving blood from a treatment chamber in the body vessel via anaspiration port, delivering a chemical agent to the treatment chambervia an injection port, maintaining the chemical agent in the treatmentchamber for a predetermined period of time to seclude the body vesselwithin the treatment chamber, and removing the chemical agent from thetreatment chamber via the aspiration port. In such embodiments, theaspiration port is operably coupled to an aspiration port lumen of avessel seclusion device, and the injection port is operably coupled toan injection port lumen of the vessel seclusion device. In someembodiments, the body vessel comprises at least one of a varicose vein,a portal vein, a perforator vein, a superficial vein, a peripheral vein,an arteriovenous malformation, or any combination thereof.

In accordance with certain embodiments, maintaining the chemical agentin the treatment chamber for the predetermined period of time comprisesmaintaining the chemical agent in the treatment chamber from about 1second to about 60 seconds. In some embodiments, the chemical agentcomprises a sclerosing agent.

In accordance with certain embodiments, the method further comprisesinserting a guide wire into the body vessel via a central lumen of thevessel seclusion device. In such embodiments, the method furthercomprises inserting at least a portion of the vessel seclusion deviceinto the body vessel via the guide wire. In further embodiments, themethod further comprises positioning the vessel seclusion device withthe body vessel via ultrasound. In some embodiments, the method furthercomprises inflating a distal balloon and a proximal balloon of thevessel seclusion device within the body vessel to define the treatmentchamber. In such embodiments, inflating the distal balloon and theproximal balloon comprises separately inserting a fluid into the distalballoon via a distal balloon lumen and inserting the fluid into theproximal balloon via a proximal balloon lumen.

In yet another aspect, certain embodiments provide a method forsecluding a body vessel. According to certain embodiments, the methodincludes selecting a seclusion length of the body vessel such that theseclusion length has a starting point and an ending point, dividing theseclusion length into at least two treatment chambers, secluding thefirst treatment chamber with a vessel seclusion device, moving thevessel seclusion device to the second treatment chamber, and secludingthe second treatment chamber. In such embodiments, the first treatmentchamber is defined by the starting point and a first intermediate point,and the second treatment chamber is defined by the first intermediatepoint and the ending point. In some embodiments, secluding each of thefirst treatment chamber and the second treatment chamber comprisesremoving blood from the treatment chamber in the body vessel via anaspiration port, delivering a chemical agent to the treatment chambervia an injection port, maintaining the chemical agent in the treatmentchamber for a predetermined period of time to seclude the body vesselwithin the treatment chamber, and removing the chemical agent from thetreatment chamber via the aspiration port. In such embodiments, theaspiration port is operably coupled to an aspiration port lumen of avessel seclusion device, and the injection port is operably coupled toan injection port lumen of the vessel seclusion device. According tocertain embodiments, moving the vessel seclusion device comprisespositioning the vessel seclusion device within the body vessel viaultrasound.

In accordance with certain embodiments, the seclusion length comprisesat least three treatment chambers. In such embodiments, the firsttreatment chamber is defined by the starting point and the firstintermediate point, the second treatment chamber is defined by the firstintermediate point and a second intermediate point, and a thirdtreatment chamber is defined by the second intermediate point and theending point.

These and other modifications and variations to the invention may bepracticed by those of ordinary skill in the art without departing fromthe spirit and scope of the invention, which is more particularly setforth in the appended claims. In addition, it should be understood thataspects of the various embodiments may be interchanged in whole or inpart. Furthermore, those of ordinary skill in the art will appreciatethat the foregoing description is by way of example only, and it is notintended to limit the invention as further described in such appendedclaims. Therefore, the spirit and scope of the appended claims shouldnot be limited to the exemplary description of the versions containedherein.

What is claimed is:
 1. A device for secluding a body vessel, comprising:a distal balloon; a proximal balloon; an aspiration port positionedadjacent to the distal balloon; an injection port positioned adjacent tothe proximal balloon; and a lumen assembly, said lumen assemblycomprising a central lumen, a distal balloon lumen operably coupled tothe distal balloon, a proximal balloon lumen operably coupled to theproximal balloon, an aspiration port lumen operably coupled to theaspiration port, and an injection port lumen operably coupled to theinjection port, wherein the distal balloon and the proximal balloondefine a treatment chamber therebetween, and the aspiration port and theinjection port are positioned within the treatment chamber on the lumenassembly.
 2. The device of claim 1, wherein the central lumen isconfigured to introduce a guide wire into the body vessel.
 3. The deviceof claim 1, wherein each of the aspiration port and the injection portcomprise a port orifice and a one-way valve at the port orifice.
 4. Thedevice of claim 1, wherein the aspiration port and the aspiration portlumen are configured to remove at least one of blood, bodily fluid, achemical agent, or any combination thereof from the treatment chamber.5. The device of claim 1, wherein the injection port and the injectionport lumen are configured to deliver a chemical agent to the treatmentchamber.
 6. The device of claim 1, wherein each of the distal balloonand the proximal balloon are spherical.
 7. The device of claim 1,wherein the distal balloon comprises a distal balloon diameter, theproximal balloon comprises a proximal balloon diameter, and each of thedistal balloon diameter and the proximal balloon diameter is from about5 mm to about 20 mm.
 8. The device of claim 1, wherein the treatmentchamber comprises a length from about 3 cm to about 15 cm.
 9. A methodfor secluding a body vessel, the method comprising: removing blood froma treatment chamber in the body vessel via an aspiration port, saidaspiration port being operably coupled to an aspiration port lumen of avessel seclusion device; delivering a chemical agent to the treatmentchamber via an injection port, said injection port being operablycoupled to an injection port lumen of the vessel seclusion device;maintaining the chemical agent in the treatment chamber for apredetermined period of time to seclude the body vessel within thetreatment chamber; and removing the chemical agent from the treatmentchamber via the aspiration port.
 10. The method of claim 9, whereinmaintaining the chemical agent in the treatment chamber for thepredetermined period of time comprises maintaining the chemical agent inthe treatment chamber from about 1 second to about 60 seconds.
 11. Themethod of claim 9, wherein the chemical agent comprises a sclerosingagent.
 12. The method of claim 9, further comprising inserting a guidewire into the body vessel via a central lumen of the vessel seclusiondevice.
 13. The method of claim 12, further comprising inserting atleast a portion of the vessel seclusion device into the body vessel viathe guide wire.
 14. The method of claim 9, further comprisingpositioning the vessel seclusion device within the body vessel viaultrasound.
 15. The method of claim 9, further comprising inflating adistal balloon and a proximal balloon of the vessel seclusion devicewithin the body vessel to define the treatment chamber.
 16. The methodof claim 15, wherein inflating the distal balloon and the proximalballoon comprises separately inserting a fluid into the distal balloonvia a distal balloon lumen and inserting the fluid into the proximalballoon via a proximal balloon lumen.
 17. The method of claim 9, whereinthe body vessel comprises at least one of a varicose vein, a portalvein, a perforator vein, a superficial vein, a peripheral vein, anarteriovenous malformation, or any combination thereof.
 18. A method forsecluding a body vessel, the method comprising: selecting a seclusionlength of the body vessel, said seclusion length having a starting pointand an ending point; dividing the seclusion length into at least twotreatment chambers; secluding the first treatment chamber with a vesselseclusion device; moving the vessel seclusion device to the secondtreatment chamber; and secluding the second treatment chamber, whereinthe first treatment chamber is defined by the starting point and a firstintermediate point, and the second treatment chamber is defined by thefirst intermediate point and the ending point, and wherein secludingeach of the first treatment chamber and the second treatment chambercomprises: removing blood from the treatment chamber in the body vesselvia an aspiration port, said aspiration port being operably coupled toan aspiration port lumen of a vessel seclusion device; delivering achemical agent to the treatment chamber via an injection port, saidinjection port being operably coupled to an injection port lumen of thevessel seclusion device; maintaining the chemical agent in the treatmentchamber for a predetermined period of time to seclude the body vesselwithin the treatment chamber; and removing the chemical agent from thetreatment chamber via the aspiration port.
 19. The method of claim 18,wherein the seclusion length comprises at least three treatmentchambers, the first treatment chamber is defined by the starting pointand the first intermediate point, the second treatment chamber isdefined by the first intermediate point and a second intermediate point,and a third treatment chamber is defined by the second intermediatepoint and the ending point.
 20. The method of claim 18, wherein movingthe vessel seclusion device comprises positioning the vessel seclusiondevice within the body vessel via ultrasound.